FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MUMPS COMPLEMENT FIXATION & HEMAGGLU
K Number: K832873
·
Decision Dec 27, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
1
Review Days
124
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Basic Information
- Device Name
- MUMPS COMPLEMENT FIXATION & HEMAGGLU
- K Number
- K832873
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3380
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hazleton Dutchland, Inc.
- Date Received
- August 25, 1983
- Decision Date
- December 27, 1983
- Product Code
- GRC
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GRC | Antigen, Cf (Including Cf Control), Mumps Virus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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